Overview

This trial is active, not recruiting.

Condition non-hodgkin's lymphoma
Treatment rituximab, bendamustine, mitoxantrone, dexamethasone
Phase phase 2
Sponsor Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Start date July 2009
End date December 2013
Trial size 60 participants
Trial identifier NCT01133158, R-BMD GELTAMO 08

Summary

Assess the combination of efficacy of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
rituximab, bendamustine, mitoxantrone, dexamethasone
Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv DEXAMETHASONE 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv

Primary Outcomes

Measure
The primary endpoint is the complete response and unconfirmed complete response according to the criteria of the International Workshop to Standardize Response Criteria for NHL
time frame: 4 years

Secondary Outcomes

Measure
Secondary endpoints included an assessment of the following parameters:Global Survival, Progression-Free Survival, Disease-Free Survival,Duration of the Response.
time frame: 4 years
Security of bendamustine in combination with dexamethasone,Mitoxantrone and Rituximab.
time frame: 4 years

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: 1. Age ≥ 18 and ≤ 75 years. 2. Patients with follicular lymphoma grade 1, 2 or 3a, CD20 +, histologically confirmed lymph node biopsy or tissue. Be accepted diagnosis in bone marrow if no accessible lymph nodes and whether it has discarded the mantle LLC, and NHL. 3. Follicular lymphoma patients treated with the combination of rituximab and chemotherapy in first line, which have been refractory or relapsed after having achieved any responses to this first line of pretreatment (excluding radiotherapy). 4. ECOG ≤ 2. 5. Signed written informed consent. Exclusion Criteria: 1. Clinical suspicion or documentation of histological transformation. 2. Have received prior chemotherapy scheme, first line without Rituximab. 3. Prior autologous or allogeneic. 4. CNS infiltration by LF (primary CNS lymphoma or lymphomatous meningitis). 5. Past or active Hepatitis B (at least one of the following markers HBsAg, HBe Ag, anti-HBc, HBV DNA) 6. HCV infection. HIV infection or other conditions of serious immunosuppression. 7. Previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated. 8. Cardiac function in cardiac patient known or prior treatment with anthracyclines with EF <50%. 9. Impaired renal function (creatinine> 1.5 x Upper Limit of Normal, LSN) or a creatinine clearance <50 ml / h, not related to lymphoma. 10. Impaired liver function (bilirubin, AST / ALT or GGT> 2 x ULN) were not related to lymphoma. 11. Women who are nursing or pregnant. Women of childbearing potential will be included prior pregnancy test serum / urine negative. Use effective contraception to be kept for 1 year after cessation of rituximab. 12. Patients with heart disease, pulmonary, neurological, psychiatric or severe metabolic and not secondary to lymphoma. 13. Severe acute or chronic infection in activity. 14. Any other concurrent medical or psychological comorbidity that might interfere with participation in this study.

Additional Information

Official title Study Phase II Non-randomized Prospective Open to Assess the Combination of Rituximab, Bendamustine, Mitoxantrone, Dexamethasone (R-BMD) in Patients With Follicular Lymphoma Refractory or Relapsed
Principal investigator Francisco Javier Peñalver Párraga, MD
Description Assess the combination of efficacy and safety of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma who are refractory or in relapse.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea.